ML22189A040

Fitness for Duty Program Performance and Trends and Regulatory Updates, 2021

ML22189A040
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Issue date:	07/14/2022
From:	Brian Zaleski NRC/NSIR/DPCP/RSB
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Zaleski B
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ML22189A032	List: ML22189A035 ML22189A040
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Download: ML22189A040 (32)

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Presentation to the Nuclear Energy Institutes Access Authorization and Fitness for Duty Workshop Fitness for Duty Program Performance and Trends and Regulatory Updates July 14, 2022

Discussion Topics FFD Program Performance in 2021 and Trends Regulatory Updates:

Part 26/HHS Guidelines Final Rule Part 73 Access Authorization Slide 2

FFD Program Performance and Trends Note: 2021 FFD Program Performance results are DRAFT.

NRC finalizing the standard quality assurance and quality control process to validate the information received.

Slide 3

FFD Program Performance Results by Test and Employment Categories, 2021 Percent Test Category Tested Positive Positive Pre-Access 63,044 733 1.16%

Random 45,528 274 0.60%

For Cause 260 39 15.00%

Post-Event 360 3 0.83%

Followup 5,016 51 1.02%

Total 114,208 1,100 0.96%

Licensee Employees Contractor/Vendors Total

% of Total Test Category Percent Percent Percent Tested Positive Tested Positive Tested Positive Positives Positive Positive Positive Pre-Access 7,825 46 0.59% 55,219 687 1.24% 63,044 733 1.16% 66.6%

Random 28,575 79 0.28% 16,953 195 1.15% 45,528 274 0.60% 24.9%

For Cause 69 7 10.14% 191 32 16.75% 260 39 15.00% 3.5%

Post-Event 75 - 0.00% 285 3 1.05% 360 3 0.83% 0.3%

Followup 2,284 17 0.74% 2,732 34 1.24% 5,016 51 1.02% 4.6%

Total 38,828 149 0.38% 75,380 951 1.26% 114,208 1,100 0.96% 100.0%

Slide 4

FFD Program Performance Results, 2017-2021 2017 2018 2019 2020 2021 Number of Facilities Reporting 72 71 70 70 69 Individuals Tested 148,741 145,797 131,417 124,678 114,208 Individuals Testing Positive* 1,176 1,187 1,085 1,047 1,100 Identified at Pre-access Testing 64.4% 69.6% 67.3% 67.4% 66.6%

Identified at Random Testing 22.5% 17.8% 21.8% 22.7% 24.9%

Pre-Access Testing Positive Rates 0.93% 1.02% 1.03% 1.01% 1.16%

Licensee Employee 0.42% 0.43% 0.44% 0.40% 0.59%

Contractors/Vendors 0.93% 1.08% 1.10% 1.08% 1.24%

Random Testing Positive Rates 0.45% 0.37% 0.45% 0.49% 0.60%

Licensee Employees 0.14% 0.17% 0.19% 0.23% 0.28%

Contractors/Vendors 0.90% 0.68% 0.86% 0.92% 1.15%

• Positive = Positive drug and alcohol tests, adulterated and substituted validity test results, and refusals to test All results in presentation are MRO verified Slide 5

Pre-Access Testing (1990-2021)

Positive Rates by Employment Category 1.6%

1.54%

1.4%

Contractor/Vendors 1.24%

1.2%

Percent Positive 1.0%

0.95%

0.8%

Licensee Employees 0.59%

0.6%

0.4%

0.2%

0.0%

1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 Slide 6

Pre-Access Testing, 2021 Distribution of Site-Specific Positive Rates by Employment Category Slide 7

Random Testing (1990-2021)

Positive Rates by Employment Category 1.2%

1.15%

1.0%

Percent Positive Contractor/Vendors 0.8%

0.6% 0.56%

0.4%

0.28% 0.28%

Licensee Employees 0.2%

0.0%

1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 Slide 8

Random Testing (2017-2021)

Distribution of Site-Specific Positive Rates by Employment Category Positive Rate Licensee Employee Contractor/Vendor Range (%) 2017 2018 2019 2020 2021 2017 2018 2019 2020 2021 0 37 29 34 30 25 32 28 35 26 26

> 0% - 0.25% 20 22 17 17 11 1 4 1

> 0.25% - 0.5% 12 16 15 10 18 10 14 6 6 5

> 0.5% - 0.75% 2 4 3 8 12 13 6 6 8 7

> 0.75% - 1% 1 4 1 6 10 6 5 7

> 1% - 1.25% 1 4 5 5 10 5

> 1.25% - 1.5% 1 1 7 3 3

> 1.5% - 1.75% 1 2 1 3 4 5

> 1.75% - 2% 1 1 4 2

> 2% - 2.25% 1

> 2.25% - 2.5% 1 1 3

> 2.5% - 2.75% 1 1

> 2.75% - 3%

> 3% - 3.25%

> 3.25% - 3.5% 1

> 3.5% - 3.75% 1 2

> 3.75% - 4% 1

> 4% 1 1 1 Slide 9

Results by Employment Category, 2021 Licensee Employees Contractor/Vendors (38,828 tested, 149 individuals positive) (75,380 tested, 951 individuals positive)

Cocaine 6.0%

Refusal to Test Cocaine 5.3% 8.5% Refusal to Test 20.7%

Alcohol Amphetamines 40.7%

3.3% Alcohol 12.1% Amphetamines Opiates 8.5% Opiates 1.3%

0.6%

Marijuana 43.3% Marijuana 49.5%

n = 150 n = 998 Slide 10

Detection Trends - NRC Testing Panel Percentage of Total Positives by Substance Tested 60.0%

marijuana Percent of Total Positives 50.0%

40.0%

30.0%

cocaine alcohol 20.0%

10.0%

amphetamines opiates 0.0% PCP 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 Since at least 2014, this chart under reports the substances used by individuals with a drug testing violation. This is because of the high number of subversion attempts where no specimen is tested (at least 60% of subversion attempts each year)

Slide 11

Alcohol Positive Results, 2021 Effectiveness of Lower Cutoff Levels 0.03 and in work status at least 1 hr

• 38% of alcohol positives due to timedependent 34 0.02 and in cutoff levels (BAC < 0.04) work status at least 2 hrs 35

• Must abstain from alcohol use at least 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> 0.04 or prior to arrival for work greater 113 n = 182 Slide 12

Results by Labor Category, 2021 Slide 13

Total Substances by Labor Category, 2021 Maintenance (general facility) 812 Facility Support 107 Other 67 Security 59 Engineering 22 HP/RP 21 Supervisor 16 Non-Licensed Operator 16 Maintenance (safety-significant) 15 Licensed Operator 7 QA/QC 4 FFD Program Personnel 1 SSNM Transporter 0 Slide 14

Subversion Attempt Trends (2016-2021)

Subversion attempt: Any willful act or attempted act to cheat on a required test (e.g., refuse to provide a specimen, alter a specimen with an adulterant, provide a specimen that is not from the donors body) 2016 2017 2018 2019 2020 2021 Number of Subversion Attempts 305 305 298 307 288 273 Percentage of Drug Testing Violations 32.4% 31.9% 31.0% 34.5% 34.4% 29.6%

Identified at Pre-access Testing 72.1% 67.5% 77.5% 73.3% 74.7% 71.3%

Committed by Contractor/Vendors 98.0% 97.7% 95.6% 97.4% 96.2% 94.5 Percentage of Sites Reporting 53% 64% 70% 61% 72% 71%

At Least One Subversion Subversion attempt sanction:

Permanent denial unescorted access,10 CFR 26.75(b)

Slide 15

Subversion Attempt Road Map, 2021 Slide 16

Subversion Attempt Trends by Labor Category (2016-2021)

Labor Category 2016 2017 2018 2019 2020 2021 Total Maintenance (general facility) 158 193 226 255 245 219 1,296 Other 124 77 16 7 6 6 236 Facility Support 10 17 25 18 17 26 113 Maintenance (safetysignificant) 10 9 14 10 10 2 55 Security 4 4 6 4 9 27 Supervisor 2 1 7 4 1 2 17 HP/RP 2 2 2 1 6 13 Engineering 1 2 3 4 10 NonLicensed Operator 1 2 3 6 QA/QC 2 2 Maintenance (craft) 1 1 FFD Program Personnel Licensed Operator SSNM Transporter Total 305 305 298 307 288 273 1,776 Slide 17

Special Analyses Limit of Detection Testing of Dilute Specimens, 10 CFR 26.163(a)(2)

Slide 18

HHS-Certified Laboratory Performance, 2021

• Specimen shipments impacted by a severe weather event (snowstorm) that shut down a major express mail service shipping hub

• Shipments of specimens lost in transit to laboratory

• Specimen testing delays (not meeting 5-business day test result reporting requirement under 10 CFR 26.169)

• One laboratory (Quest Diagnostics - Tucker, GA) ceased operations, which impacted a number of licensee FFD programs Slide 19

Part 26/HHS Guidelines Draft Final Rule Slide 20

Part 26 Rulemaking (RIN 3150-AI67; Docket NRC-2009-0225)

Aligning Part 26 drug testing requirements more closely with the U.S. Department of Health and Human Services 2008 and 2017 Mandatory Guidelines for Federal Workplace Drug Testing of urine specimens. Also incorporating lessons learned from implementing Part 26.

• Final Rule approved by Commission March 2022

• Expect Final Rule to be published in October 2022

• Substantive changes:

Add testing for MDMA, MDA, hydrocodone, hydromorphone, oxycodone, oxymorphone Lower drug testing cutoff levels for amphetamine, methamphetamine, cocaine Improve testing method to identify heroin Improve methods to detect donor subversion attempts Include option to collect and drug test oral fluid for observed collection conditions Slide 21

Part 26, Draft Final Rule:

Drug Testing Panel Changes Testing Cutoff Levels (ng/mL)

Drugs or drug metabolites Initial Confirmatory Cocaine metabolites 300150 150100 Opioids Opiate metabolites:

6-acetylmorphine (6-AM) 10 101 Hydrocodone 100 300 Hydromorphone 100 Oxycodone 100 100 Oxymorphone 100 Amphetamines Amphetamine 500250 1000500 Methamphetamine 5002502 Methylenedioxymethamphetamine (MDMA) 250 500 Methylenedioxyamphetamine (MDA) 250 1 Confirmatory testing for 6-AM performed only when morphine concentration exceeds 2,000 ng/mL 2 To be reported positive for methamphetamine, a specimen must also contain amphetamine at a concentration equal to or greater than 200100 ng/mL Only substances with changes displayed Slide 22

Part 26, Draft Final Rule:

Subversion Detection Enhancements Special analyses testing under 26.163(a)(2):

• Required for dilute specimens (before optional)

• Required for specimens collected under direct observation conditions:

26.115(a)(1)-(a)(3), and (a)(5) [new]

• Change drug concentration on initial test that triggers special analyses testing (from 50% of cutoff to 40% of cutoff)

• Change confirmatory testing cutoff to Limit of Quantitation (LOQ) from the Limit of Detection (LOD)

Validity testing cutoff levels under 26.161(h):

• Permit use of more stringent cutoffs for validity tests than specified in Part 26 only if testing is performed at an HHS-certified laboratory (before, use of more stringent cutoffs levels prohibited)

Slide 23

Part 26, Draft Final Rule: Additional Changes

• Donor protections:

- Verbal request for retest (MRO document request)

- MRO review of invalid specimens - pH 9.0 to 9.5 (handling conditions)

• Hydration monitor: permit an individual other than the original specimen collector to monitor a donor with a shy-bladder

• Issuing a new Regulatory Guide 5.89 that covers three topics specific to the final rule (observed collections, donor hydration during shy-bladder events, MRO review of invalid specimens - pH 9.0 to 9.5)

• Revising NRC Form 890, Single Positive Test Form, and NRC Form 891, Annual Reporting Form for Drug and Alcohol Tests All Draft Final Rulemaking documents available at:

https://www.nrc.gov/docs/ML2111/ML21111A017.html Slide 24

Part 26 Final Rule -

Implementation Considerations

• Revise FFD policies and procedures

• Revise contracts with HHS-certified laboratory(ies)

• Update blind performance test samples consistent with revised drug testing panel (cutoff level changes for existing substances, addition of new substances)

• Provide training to covered personnel on rule changes

• If utilizing a Licensee Testing Facility, obtain and validate drug testing assays consistent with testing panel and cutoff level changes, train laboratory technicians.

Slide 25

Access Authorization - 10 CFR Part 73 Regulatory Updates Slide 26

Access Authorization:

Discussion Topics

• Draft Regulatory Issue Summary (RIS), Personnel Access Authorization Requirements for Non-Immigrant Foreign Nationals Working at Nuclear Power Plants

• Regulatory Guide (RG ) 5.77 Insider Mitigation Program (Status)

• NRC/FBI RAP Back Initiative

• Controlled Unclassified Information (CUI)

Slide 27

DRAFT RIS: Personnel Access Authorization Requirements for Non-Immigrant Foreign Nationals Working at Nuclear Power Plants

• Published for public comment on June 13, 2022 (87 FR 35798)

[Comment period closes August 12, 2022]

• The NRC, in collaboration with the Department of Homeland Security, identified several instances where a licensee failed to appropriately verify the claimed non-immigration status of a foreign national seeking unescorted access (UA) and/or unescorted access authorization (UAA),

which resulted in individuals being granted UA/UAA at U.S. nuclear power plants [did not have visa category that permitted work in the U.S]

• Verification of foreign national employment eligibility (correct non-immigration status) is a required aspect of true-identity verification under 10 CFR 73.56(d)(3) (visual inspection of a document/credential is not sufficient, independent verification is necessary using an authoritative resource)

• NRC Technical Lead: Mark Resner Slide 28

RG 5.77 Insider Mitigation Program (Revision 1) - Status The Commission approved issuance of Revision 1 to RG 5.77 on July 14, 2021 (Staff Requirements MemorandumSECY-17-0095) (ML21195A356)

• Before issuing Revision 1, the Commission directed the staff to:

Edit the document for consistency, accuracy, formatting, and a determination regarding which content should be marked Unclassified and Official Use Only - Security Related Information Provide the revised guidance to the Commission in a Commissioners Assistants (CA) note, including notifying the Commission of any recommended substantive changes based on information and experience gained since this paper was submitted to the Commission

• The revised guidance is in the concurrence process

• NRC Technical Lead: Brad Baxter Slide 29

NRC/FBI RAP Back Initiative

• The Records of Arrest and Prosecution (RAP) Back Service is a feature of the FBI Next Generation Identification System (NGI). It provides continual monitoring of arrests/criminal activity of enrollees with fingerprints on file.

• The NRC signed an MOU with FBI/DOJ on January 16, 2020

• Cooper Nuclear Station is the first licensee site to participate:

- Signed MOU with the NRC: March 3, 2020

- Licensee enrollment rollout began: May 6, 2021 (Public meeting was held as part of this rollout - ML21125A037)

• RAP Back is provided by the FBI at no cost

• NRC Technical Lead: Mark Resner Slide 30

Controlled Unclassified Information (CUI) Program

• On November 12, 2021, the NRC issued a final policy statement in the Federal Register to describe how the agency will comply with regulations issued by the National Archives and Records Administration to implement a CUI program (https://www.federalregister.gov/documents/2021/11/12/2021-24543/controlled-unclassified-information-program).

• On June 2, 2022, the NRC held a public meeting with stakeholders to discuss topics such as information-sharing agreements related to NRC's plans to transition from Sensitive Unclassified Non-Safeguards Information (SUNSI) to CUI.

• The NRC has reached out to the FBI to discuss the implications of CUI on Criminal History Information.

Slide 31

NRC Program Staff FFD and Access Authorization Office of Nuclear Security and Incident Response Mark Resner, Senior Security Specialist (Access Authorization)

Mark.Resner@nrc.gov (301-287-3680)

Paul Harris, Senior Program Manager (Fitness for Duty)

Paul.Harris@nrc.gov (301-287-9294)

Brad Baxter, Security Specialist (Access Authorization)

Brad.Baxter@nrc.gov (301-287-3615)

Brian Zaleski, Specialist - Fitness-for-Duty/Access Authorization Brian.Zaleski@nrc.gov (301-287-0638)

Slide 32